NCT00361660

Brief Summary

The first purpose of this study is to determine how often people should practice motor skills to best improve the ability to use the affected arm and hand after stroke. The second purpose is to determine whether it is better to practice a lot of repetitions of a few tasks or a few repetitions of many tasks during motor rehabilitation for the arm and hand after stroke.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2006

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 8, 2006

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 26, 2015

Status Verified

June 1, 2015

Enrollment Period

1 year

First QC Date

August 7, 2006

Last Update Submit

June 25, 2015

Conditions

Keywords

Motor skillsOccupational TherapyPhysical Therapy TechniquesRehabilitationUpper ExtremityStroke

Outcome Measures

Primary Outcomes (1)

  • Upper extremity subscale of the Fugl-Meyer Motor Assessment

    immediately after therapy ends

Secondary Outcomes (1)

  • Wolf Motor Function Test

    Immediately after therapy ends

Study Arms (2)

1

EXPERIMENTAL

Therapy is provided every other day 3 days per week (Monday, Wednesday, Friday).

Behavioral: functional task practice - distributed

2

ACTIVE COMPARATOR

The same therapy is provided daily Monday through Friday

Behavioral: functional task practice - condensed

Interventions

This functional task practice is modeled after Constraint-Induced Movement Therapy in which participants wear a mitt on the non-paretic arm for up to 90% of waking hours and then attend therapy for 3 hours a session Monday, Wednesday, and Friday in which they practice various functional tasks, such as tracing a stencil, placing toothbrushes in toothbrush holders, etc.

Also known as: constraint-Induced Movement Therapy
1

This functional task practice is modeled after Constraint-Induced Movement Therapy in which participants wear a mitt on the non-paretic arm for up to 90% of waking hours and then attend therapy for 3 hours a session Monday through Friday in which they practice various functional tasks, such as tracing a stencil, placing toothbrushes in toothbrush holders, etc.

Also known as: Constraint-Induced Movement Therapy
2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hemiparesis due to unilateral stroke at least 3 months prior
  • years of age
  • able to extend the paretic wrist 200 and at least 1 finger 100
  • able to follow 2-step commands
  • score \< 3 on the Motor Activity Log Amount of Use scale

You may not qualify if:

  • have no medical or orthopedic condition that would significantly limit ability to participate in the intervention or benefit from the therapy
  • have no history of other major neurologic or psychiatric condition or injury, and have no active drug or alcohol abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeHemiplegia

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Lorie G Richards, PhD

    North Florida/South Georgia Veterans Health System

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

August 7, 2006

First Posted

August 8, 2006

Study Start

August 1, 2006

Primary Completion

August 1, 2007

Study Completion

December 1, 2007

Last Updated

June 26, 2015

Record last verified: 2015-06